After meeting with representatives of the Committee for Medicinal Products for Human Use (CHMP) and Secretariat of the European Medicines Agency (EMEA), IDM Pharma announced that they will provide an update responding to the remaining open issues in its Marketing Authorization Application (MAA) for mifamurtide (L-MTPPE) for the treatment of patients with non-metastatic, resectable osteosarcoma.

The company will present the additional information at the meetings held by CHMP Scientific Advisory Group on Oncology scheduled for November. The MAA for L-MTP-PE was submitted to the EMEA and accepted for regulatory review in November 2006.

Thus far, the CHMP has accepted Phase III trial information submitted by IDM Pharma, and awaits the further information to be presented in November 2008. The company is confident that they will receive a final decision from the European Commission in the first quarter of 2009.

In the United States, the company submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in October 2006 and received a non-approvable letter in August 2007.

L-MTP-PE will be the first treatment in more than 20 years approved for patients with osteosarcoma, a rare and fatal type of bone tumor most prevalent in children and young adults. The product is a liposomal formulation of MTP-PE (Muramyl Tripeptide Phosphatidylethanolamine) specifically designed for in vivo targeting of macrophages by intravenous infusion.

Source: IDM Pharma, Inc.